Mazor X System

GUDID 07290115751376

MAZOR ROBOTICS LTD

Multi-purpose stereotactic surgery system
Primary Device ID07290115751376
NIH Device Record Keyc21ae871-6a58-49bf-a2bd-34a50d08cf1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMazor X System
Version Model NumberTPL0059-09
Company DUNS532681590
Company NameMAZOR ROBOTICS LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290115751376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-18
Device Publish Date2022-01-06

On-Brand Devices [Mazor X System]

07290109183213TPL0059-06
07290109181158TPL0059-05
07290109180465Mazor X System
17290109180465TPL0059-03
07290109184838TPL0059-08
07290109184098TPL0059-07
07290115751376TPL0059-09

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